Genentech Withdraws Tecentriq Indication; New Approvals for Xarelto, Tibsovo

Tecentriq received accelerated FDA approval for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Continued approval was conditional on the results of IMpassion131, a post-marketing requirement required by the FDA. This study failed to meet the primary endpoint of progression-free survival for first-line treatment of people with mTNBC.

Although the FDA Oncology Drugs Advisory Committee voted 7 to 2 on April 27, 2021 in favor of maintaining Tecentriq’s accelerated approval, Genentech officials have made the decision to withdraw the indication due to changes in the treatment landscape, they said in a statement. declaration.

One of those changes was the accelerated approval of Merck’s Keytruda (pembrolizumab) in November 2020 for the same indication.

FDA clears expanded indication for Xarelto.

The FDA has approved an expanded peripheral vascular disease indication for the Janssen’s Xarelto (rivaroxaban) to admit patients after recent lower extremity revascularization.

With this approval, Xarelto is the first therapy indicated to help reduce the risks of serious cardiovascular events in patients with coronary artery disease and serious thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia and major amputation of a vascular etiology , in patients with peripheral vascular disease.

Peripheral artery disease is a chronic circulatory disease that causes blood vessels to narrow, reducing blood flow to the extremities, usually the legs. It is a disease that is often undiagnosed and undertreated. In fact, an estimated 20 million Americans are living with the disease, but only 8.5 million are currently diagnosed. It is the leading cause of amputations in the United States.

Xarelto now has nine indications.

FDA Approves Tibsovo for Rare, Aggressive Cancer.

The FDA has approved Tibsovo (ivosidenib) from Servier Pharmaceuticals for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1. TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts inside and outside the liver.

Each year, an estimated 8,000 people in the United States are diagnosed with cholangiocarcinoma. But the true number of these cases is likely higher, as this cancer is difficult to diagnose and can be misclassified as other cancers.

At the same time, the FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for Tibsovo.

The Oncomine Dx Target Test is a next-generation sequencing (NGS)-based test that provides reproducible results in the IDH1 gene clinically associated with CCA. The FDA first approved the test as a CDx in 2017 and is now approved for four targeted therapies for non-small cell lung cancer and one targeted therapy for CCA in the United States. The test is currently approved and reimbursed by government and commercial insurers in more than 15 countries.

FDA approves long-acting growth hormone.

The FDA has approved Skytrofa (lonapegsomatropin-tcgd), developed by Ascendis Pharma for the treatment of children one year of age and older with growth retardation. This is the first FDA-approved product to deliver somatropin by sustained release over a week.

With a growth hormone deficiency, the pituitary gland does not produce enough growth hormone, which is important not only for height, but also for a child’s overall endocrine health and development.

The approval is based on the results of the Phase 3 heiGHt trial, a 52-week, global study comparing once-weekly therapy with daily somatropin (Genotropin) in 161 treatment-naïve children. No serious adverse events or discontinuations related to therapy were reported.

The weekly therapy uses TransCon technology, which was developed by Ascendis. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and protects the parent drug from clearance. Because the drug is unchanged, its original mechanism of action is expected to be preserved, Ascendis officials said.

FDA approves drug for itching associated with kidney disease.

The FDA has approved Korsuva (difelikefalin) for the treatment of patients with moderate to severe pruritis or itchy skin associated with chronic kidney disease in adults on hemodialysis. Korsurva, developed by Cara Therapeutics and Vifor Pharma, is a premium kappa opioid receptor agonist that targets the body’s peripheral nervous system.

The approval is based on positive data from two pivotal Phase 3 studies, as well as supporting data from an additional 32 clinical trials. Korsuva was generally well tolerated.

Vifor Pharma expects to be able to market the therapy in the first quarter of 2022.

BMS submits an additional application for Orencia.

The FDA has accepted Bristol-Myers Squibb’s additional Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate-to-severe acute graft-versus-host disease (aGvHD) in patients 6 years of age and older who are not -related donor receive hematopoietic stem cell transplant (HSCT). The FDA granted the application priority review and assigned a PDUFA target date of December 23, 2021.

If approved, Orencia would become the first therapy for the prevention of aGvHD.

The sBLA filed with the FDA is based on results from the Phase 2 ABA2 trial and a registry study based on real-world evidence. The ABA2 study assessed the impact of Orencia on the prevention of severe aGvHD when added to a standard GvHD prophylactic regimen.

Orencia is approved for the treatment of adults with rheumatoid arthritis and psoriatic arthritis, as well as children with polyarticular juvenile idiopathic arthritis.

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